Cleared Traditional

KAVO KEY LASER 1242 AND KAVO KEY LASER 1243+

K030146 · Kavo America · Dental

Aug 2005

Decision

931d

Days

Class 2

Risk

About This 510(k) Submission

K030146 is an FDA 510(k) clearance for the KAVO KEY LASER 1242 AND KAVO KEY LASER 1243+, a Laser, Dental, Soft Tissue (Class II — Special Controls, product code NVK), submitted by Kavo America (Lake Zurich, US). The FDA issued a Cleared decision on August 3, 2005, 931 days after receiving the submission on January 15, 2003. This device falls under the Dental review panel. Regulated under 21 CFR 878.4810.

Submission Details

510(k) Number	K030146 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 15, 2003
Decision Date	August 03, 2005
Days to Decision	931 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF

Device Classification

Product Code	NVK — Laser, Dental, Soft Tissue
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 878.4810
Definition	Intended For The Incision, Excision, Cutting, Ablation, And Vaporization Of Soft Tissue In Oral And Maxillofacial Surgery And Dentistry.